Identity
- Trade Name
- NIM-ECLIPSE® FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- CONTROLLER 945ECLCLO LOANER ECLIPSE FDA UDI
- Model / Reference
- 945ECLCLO FDA UDI
- Description
- CONTROLLER 945ECLCLO LOANER ECLIPSE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169020252 FDA UDI
- 510(k) Number
- K061639 FDA UDI
- FDA Product Code
- ITX FDA UDIGWJ FDA UDIGWQ FDA UDIIYN FDA UDIGWE FDA UDIGWF FDA UDI
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI882.1900 FDA UDI882.1400 FDA UDI892.1550 FDA UDI882.1890 FDA UDI882.1870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nerve-locating system
Nim-Eclipse® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-locating system.
- Guardian Probe Extension, 4 cm — Checkpoint Surgical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- SENTIO — Medos International Sàrl · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
Cleared under the same submission
K061639 also covers:
- NIM-ECLIPSE® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM-Eclipse® — MEDTRONIC SOFAMOR DANEK, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM Eclipse — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC.
- NIM-ECLIPSE® — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 466ccfe6-b8b2-4367-81b3-a5848de7126b 36 fields · synced May 30, 2026